A Phase 2, Double-Blind, Randomized, Parallel-Group, Controlled, Repeat Dose, Single Center Study to Evaluate the Safety and Efficacy of RT001, a Botulinum Toxin Type A Topical Gel, for the Treatment of Moderate to Severe Lateral Canthal Lines In Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The number of subjects classified as exhibiting improvement via the Investigator Global Assessment from Baseline (Day 0) to End of Study (Week 6).
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of 2 sequential doses of RT001 compared to vehicle control following applications at Baseline (Day 0) and Week 2.
详细描述
This is a double-blind, randomized, parallel-group, controlled, repeat dose, single center study to evaluate the safety and efficacy of repeat application of RT001 in at least 30 subjects with moderate to severe lateral canthal lines. Subjects will be randomized to 1 of 2 treatment groups in a 1:1 ratio (RT001 Dose A or vehicle control).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female/male ages 30 to 55
- •Bilateral lateral canthal lines rated as moderate or advanced.
- •Willing to refrain from any product that affects skin remodeling or a product that may cause an active dermal response in the treatment area beginning at screening through Week
- •Women of child baring potential must practice and be willing to continue to use an effective method of birth control.
排除标准
- •Muscle weakness or paralysis in the area receiving treatment.
- •Active skin disease or irritation at treatment areas.
- •Undergone any procedures that may affect the lateral canthal region during the past 12 months prior to screening.
- •Previous treatment with botulinum toxin (any serotype) in the head or neck area within 9 months prior to Baseline (Day 0).
- •Use of topical steroid on either of the treatment areas or use of medications that suppress the immune system 30 days prior to screening and continuing through End of Study (Week 6).
- •Any abnormality on the electrocardiogram (ECG) at screening or any history of clinically significant arrhythmia, unstable angina, myocardial infarction or congestive hear failure.
研究组 & 干预措施
1
RT001 (Botulinum Toxin Type A Topical Gel)
干预措施: RT001 (Botulinum Toxin Type A Topical Gel) (Drug)
2
Vehicle Control
干预措施: Vehicle Control (Other)
结局指标
主要结局
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment from Baseline (Day 0) to End of Study (Week 6).
时间窗: Baseline (Day 0) and Week 6
Incidence of treatment emergent AEs.
时间窗: Baseline (Day 0) and Week 6
次要结局
未报告次要终点